grepcent public filings, reorganized for comparison

DEXTENZA — FDA application NDA208742

Application NDA208742 · type NDA · FDA status: approved · original approval 2018-11-30

Listed sponsor: OCULAR THERAPEUTIX · OCUL company profile · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

FDA application facts

ProductFDA-listed trade nameActive ingredientDosage formRouteStrengthMarketing statusTE codeRLD
001DEXTENZADEXAMETHASONEINSERTOPHTHALMIC0.4MGPrescriptionnot listedYes

Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.

Orange Book patent and exclusivity listings

ListingProductDescriptive dateFlags/code
Patent 8563027001listed patent expiry date: 2030-02-12U-2487
Patent 8409606001listed patent expiry date: 2030-05-14drug product
Patent 12150896001listed patent expiry date: 2036-10-07U-1680
Patent 12150896001listed patent expiry date: 2036-10-07U-3455
Patent 11458041001listed patent expiry date: 2037-11-16U-1680
Patent 11458041001listed patent expiry date: 2037-11-16U-3455
Patent 12144889001listed patent expiry date: 2041-04-26U-1680
Exclusivity NPP001listed exclusivity date: 2028-04-07FDA code as listed
NDA208742 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA208742 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA208742 FDA listing datesDescriptive regulatory dates only; no relationship to revenue or future sales is stated or implied.Source: Drugs@FDA and FDA Orange Book.Listed dateDated listing marker0.001.002.002018-11-301.002028-04-071.002030-02-121.002030-05-141.002036-10-071.002037-11-161.002041-04-261.00

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

Compound cross-links

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

Related pages

Sponsor company · FDA-approved application index

Peer clusters: No published peer-cluster link for this sponsor.

Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.